Which patient organisations were involved in the development of the SMILE pilot study?

Which ME and CFS patient organisations were involved in the development of the SMILE Lightning Process pilot study in children 12 to 18 years?

Shortlink: http://wp.me/p5foE-3c8

In her response to the ME Association, Joan Kirkbride, Head of Operations, NRES, has said:

Given that this treatment is currently available, ME Association survey data suggests it has a similar profile to other therapies and the split opinions in the ME community (this study has the support of particular ME charities who have also been involved in its planning), we feel that a fair way forward is to seek the responses of the researchers, sponsor and the ME charities involved in the development of the study before asking the REC to review its favourable opinion. We also note that in this project, subjects will not be deprived of what is current care in this clinic. Research participants will receive this intervention in addition to their standard treatment.

It is already known from the SMILE Research Protocol document that AYME has a seat on the External Advisory Group. But Ms Kirkbride’s statement suggests that more than one patient organisation may have been involved in the planning and development of this controversial pilot study.

On 24 August, I had written to Sir Peter Spencer (CEO, Action for M.E.) with a query in relation to two published position statements issued by the organisation on the proposed Lightning Process pilot study:

I had asked:


To date, there is virtually no information in the public domain about the proposed study design and methods and the research protocol is not expected to be published until the end of this month.

a) What is Action for M.E.’s understanding of what will be applied to the children during the life of the pilot study and by whom?

Where has it obtained the information on which it has based its decision to support this pilot study and to support any decision by the ethics committee(s) to grant a “favourable opinion”, ie, to approve the application?

b) Would Action for M.E. please set out what information it has relied upon in order to inform its position on this pilot and whether the organisation has made any approaches to the researchers or to any other body to obtain information about the proposed study over and above the press release, and what was the outcome of any approaches made?

Sir Peter Spencer’s response (24 August):

Our position derives from our detailed reading of the MRC Ethics Guide for medical research involving children and from our understanding of the role of any ethics committee in satisfying itself that appropriate independent arrangements are in place to ensure patient safety.”

Action for M.E. has not seen the research protocol for this proposal and has no detailed knowledge of the way in which this trial would be conducted if approved.

We do, of course, want to see research into LP in adults too – but as children are already seeing LP practitioners, before the process has been subject to research published in respected peer-reviewed journals, we can see a case for investigating if it is feasible within the Ethics Guide to set up a controlled trial.

Yesterday, 28 October, I submitted a request for information to the University of Bristol’s Information Rights Office and will update when this request has been fulfilled.  I have asked for:

1] The names of all patient organisations who have been involved in the planning/development of the SMILE pilot study.

2] The names of all members of the External Advisory Group and the organisations with which they are associated, where applicable.

Key SMILE documents

SMILE Research Protocol


Open here: smprotv6final

Research Ethics  Application Form


Open here: recfrmrfs

All published SMILE documents in this post:

Specialist Medical Intervention and Lightning Evaluation documents (Lightning Process pilot study – children [now aged 12 to 18] with CFS and ME)